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 Michael founded Umen & Co. in 1981, sensing
that the pharmaceutical industry needed a reliable
consultancy to turn to for strategic regulatory advice and
medical writing services. Since then, Michael has
contributed to numerous drug and biologic approvals,
including over 80 in the U.S. alone. The prototype documents
developed by Michael and his co-workers were the
predecessors to the regulatory document templates used today
by many of the world's leading pharmaceutical companies. He
has been working with clients on CTD implementation since
the topic was adopted by ICH. As a result of his many
accomplishments, Dr. Umen has gained worldwide recognition
as a leading regulatory strategist, problem solver, teacher,
and writer. He is a co-inventor of the Drug DocUmentation
System™ and various other drug document production systems.*
A member of the Drug Information Association
(DIA) since the mid-1970's, Michael has made numerous
contributions to the organization and was a recipient of
DIA's Outstanding Service Award in 2002. He served on the
Editorial Board of the Drug Information Journal from 1991 to
2001, has participated as a tutorial instructor, speaker,
session chairperson, and program committee member at DIA
meetings and workshops in the United States, Europe, and
Japan, and is active in several of DIA's Special Interest
Area Committees (SIACs).
Prior to founding Umen & Co., Inc., Michael
worked for two Johnson & Johnson companies. He received a
Ph.D. in organic chemistry from M.I.T., studied immunology
at Harvard Medical School, pharmacology at Philadelphia
College of Pharmacy and Science, and business at the Wharton
School.
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VCard
*Drug DocUmentation System™:
U.S.
Patent Nos.
5734883,
5963967,
6205455,
US6505218,
6854086
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